Our Verdict: RATING UNKNOWN

Orris Root, Extract (iris Florentina L.)

CAS977096-43-7

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Orris Root, Extract (iris Florentina L.) — food additive

Orris root extract is a flavoring agent derived from the rhizome of Iris florentina L., used to impart floral and slightly sweet notes to foods and beverages. It has been traditionally used in cosmetics and perfumery for centuries and is increasingly applied in food flavoring applications.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Orris Root, Extract?

Orris root extract (CAS Number: 977096-43-7) is obtained from the rhizome (underground stem) of Iris florentina L., commonly known as Florentine iris or orris. The extract contains volatile compounds and aromatic constituents that provide a distinctive floral, slightly woody, and subtly sweet flavor profile. The rhizome is typically dried and processed to concentrate its aromatic compounds, which are then used as a flavoring ingredient in food and beverage applications.

Historically, orris root has been valued in traditional medicine and perfumery for over 2,000 years. The Florentine iris is native to the Mediterranean region, particularly Italy, where it remains a primary source for commercial orris root production.

Common Uses

Orris root extract is used as a flavoring agent or flavoring adjuvant in various food and beverage products. Common applications include:

- Beverages: gin, vermouth, liqueurs, and alcoholic drinks

- Confectionery: candies, lozenges, and pastilles

- Baked goods: breads, cakes, and pastries

- Dairy products: yogurt and flavored milk beverages

- Seasonings and condiments

The ingredient is valued by food manufacturers for its ability to enhance or modify existing flavors and provide subtle aromatic complexity to products. In the fragrance industry, it continues to serve as a fixative and flavor enhancer.

Safety Assessment

Orris root extract has a long history of use, though formal safety data remains limited. The FDA has not granted GRAS (Generally Recognized as Safe) status to this ingredient, indicating that it does not meet the criteria for self-affirmation as safe without further regulatory review. However, this classification does not indicate that the substance is unsafe; rather, it reflects the lack of sufficient published safety data submitted to FDA for GRAS determination.

To date, there are zero adverse events reported to the FDA related to orris root extract, and no FDA recalls involving this ingredient have been documented. The European Union's research on orris root and related iris species suggests the ingredient has a long history of safe use at levels typically employed in food flavoring.

One notable compound in orris root is α-irone, a volatile ketone that contributes significantly to its flavor profile. Standard toxicological reviews of α-irone have not identified major safety concerns at the concentrations found in food applications.

Individuals with known allergies to iris plants or those with sensitive skin should exercise caution, as botanical extracts can occasionally trigger allergic responses in susceptible populations. The extract should not be used by persons with known Iris genus allergies without medical consultation.

Regulatory Status

Orris root extract is not currently listed as GRAS by the FDA, meaning it is not approved for unrestricted use as a food additive in the United States without specific regulatory authorization. Food manufacturers seeking to use orris root extract would need to either submit a GRAS notification to the FDA or obtain pre-market approval through the food additive petition process.

In the European Union, orris root is listed in the flavoring regulations and is permitted for use in foods under established guidelines. This distinction reflects different regulatory frameworks between regions, with the EU having established approval processes for traditional flavoring ingredients.

The ingredient is permitted in cosmetics and fragrance applications across most major regulatory jurisdictions, reflecting its long history of safe use in personal care products.

Key Studies

Limited peer-reviewed studies specifically address orris root extract's safety in food applications. Most available research focuses on the chemical composition of iris rhizomes and the identification of aromatic compounds such as α-irone, β-irone, and other volatile constituents.

Botanical safety reviews conducted by flavoring industry organizations have examined orris root within the context of traditional use patterns and chemical composition analysis. These reviews suggest that at levels used for flavoring purposes, the ingredient does not present significant toxicological concerns.

Further formal safety studies would strengthen the evidence base for GRAS determination in the United States. Researchers and manufacturers interested in establishing GRAS status would benefit from conducting or compiling acute toxicity studies, subchronic toxicity assessments, and allergenicity evaluations specific to food-grade orris root extract.

Frequently Asked Questions

What is Orris Root, Extract (iris Florentina L.)?

Orris root extract is a flavoring agent derived from the rhizome of Iris florentina L., used to impart floral and slightly sweet notes to foods and beverages. It has been traditionally used in cosmetics and perfumery for centuries and is increasingly applied in food flavoring applications.

Is Orris Root, Extract (iris Florentina L.) safe?

Orris Root, Extract (iris Florentina L.) is currently rated "unknown" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Orris Root, Extract (iris Florentina L.) banned in any country?

Orris Root, Extract (iris Florentina L.) is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.